New comprehensive biomarker panels equip physicians with clinically actionable insights for earlier, more accurate diagnosis

Amprion, a global leader advancing diagnosis of neurodegenerative disorders through seed amplification testing, is launching a new line of cerebrospinal fluid (CSF) biomarker panels: SAAmplify. Physicians and their patients will now have access to the most comprehensive set of biomarkers available to aid in the diagnosis of Parkinson’s disease, Lewy body dementia, and Alzheimer’s disease with the Lewy body variant.

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Amprion Unveils Next-Generation SAAmplify™ Biomarker Panels to Aid in Diagnosis of Neurodegenerative Disorders (Graphic: Business Wire)

Each panel leverages Amprion’s flagship seed amplification assay (SAA) that identifies misfolded ɑ-synuclein aggregates in CSF. Amprion’s SAA, originally named the SYNTap® Biomarker CSF test, has made the detection of misfolded ɑ-synuclein aggregates possible with autopsy-confirmed accuracy. The only ɑ-synuclein assay of its kind, SAA is already advancing the field, leading to a proposed new definition of the subgroup of neurodegenerative diseases characterized by abnormal accumulation of alpha-synuclein protein in the nervous system as synucleinopathies.

Since its initial launch in 2022, Amprion has made notable enhancements to the assay, further improving its sensitivity and reducing assay time. This next-generation assay will be made available under the SAAmplify brand in the second half of 2024. Additional common biomarkers, such as total Tau, pTau 181, Aβ1-42, Aβ1-40, and NfL, are combined with SAAmplify-ɑSYN in various configurations to create the new panels.

“This level of accuracy is like having a window into the brain itself,” said Russell Lebovitz, MD, PhD, CEO and co-founder of Amprion. “With these new panels, clinicians will have the biological insights to develop a diagnosis for prodromal and symptomatic patients alike, which has never before been possible. Patients navigating a potential neurodegenerative disorder diagnosis are often met with unclear answers. We’re hoping to bring some much-needed clarity to patients and their loved ones with this novel technology.”

Recently published studies in The Lancet Neurology, Alzheimer’s and Dementia, and other leading journals continue to validate the technology, demonstrating the high sensitivity and specificity of Amprion’s SAA for detecting ɑ-synuclein aggregates in CSF—all of which is also confirmed by autopsy. To review these findings, visit www.ampriondx.com/promo.

“Accurate confirmation is critical to support clinical diagnosis of disorders with Lewy-body pathology or copathology, as it allows clinicians to confidently develop a differential diagnosis based on each patient’s biology," said Marwan Sabbagh, MD, neurologist at Barrow Neurological Institute and scientific advisor for Amprion. “Symptoms can confound diagnosis, leaving patients and their caregivers without the necessary insights to optimally or effectively manage their condition."

Amprion will premiere the new SAAmplify test panels at the upcoming Alzheimer’s Association International Conference (AAIC) 2024, the largest international meeting dedicated to advancing dementia science and clinical practice. The Amprion team will be meeting with clinicians, partners and media (booth 1125). For inquiries, email Info@AmprionDx.com or visit www.ampriondx.com to learn more.

About SAAmplify-ɑSYN (formerly SYNTap®)

Amprion's SAAmplify-ɑSYN Biomarker Test is a first-in-class-qualitative Laboratory Developed Test (LDT) and the only seed amplification assay available to aid the diagnosis of synucleinopathies such as Parkinson's disease (PD), Lewy body dementia (LBD/DLB), and Alzheimer's disease (AD) with Lewy body variant. The U.S. Food and Drug Administration (FDA) granted Amprion a Breakthrough Device Designation in 2019 for use of the test as an aid in the diagnosis of PD. SYNTap became commercially available in 2021.

About Amprion

Amprion is a global leader advancing diagnosis of neurodegenerative disorders through seed amplification testing. As the global population ages, Amprion aims to accelerate precision medicine for neurodegenerative disorders by helping biopharma partners identify new drug candidates and underlying pathologies. The amplification testing methodology was originally developed by Claudio Soto, PhD, Amprion's Co-Founder and Professor at The University of Texas Health Science Center at Houston and has been further enhanced and validated by Amprion's in-house scientific team. Amprion currently holds multiple U.S. and International patents for SAA methodology and strives to launch more biomarker tests to detect a wide range of early-stage neurodegenerative disorders. For more information, visit https://ampriondx.com/ or find us on LinkedIn.

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